Virtual Reality for Subacute Pain After Orthopedic Traumatic Musculoskeletal Injuries: A Mixed Methods Pilot Study.

OBJECTIVES: Acute orthopedic traumatic musculoskeletal injuries are prevalent, costly, and often lead to persistent pain and functional limitations. Psychological risk factors (eg, pain catastrophizing and anxiety) exacerbate these outcomes but are often overlooked in acute orthopedic care. Addressing gaps in current treatment approaches, this mixed-methods pilot study explored the use of a therapeutic virtual reality (VR; RelieVRx ), integrating principles of mindfulness and cognitive-behavioral therapy, for pain self-management at home following orthopedic injury. METHODS: We enrolled 10 adults with acute orthopedic injuries and elevated pain catastrophizing or pain anxiety from Level 1 Trauma Clinics within the Mass General Brigham health care system. Participants completed daily RelieVRx sessions at home for 8 weeks, which included pain education, relaxation, mindfulness, games, and dynamic breathing biofeedback. Primary outcomes were a priori feasibility, appropriateness, acceptability, satisfaction, and safety. Secondary outcomes were pre-post measures of pain, physical function, sleep, depression, and hypothesized mechanisms (pain self-efficacy, mindfulness, and coping). RESULTS: The VR and study procedures met or exceeded all benchmarks. We observed preliminary improvements in pain, physical functioning, sleep, depression, and mechanisms. Qualitative exit interviews confirmed high satisfaction with RelieVRx and yielded recommendations for promoting VR-based trials with orthopedic patients. DISCUSSION: The results support a larger randomized clinical trial of RelieVRx versus a sham placebo control to replicate the findings and explore mechanisms. There is potential for self-guided VR to promote evidence-based pain management strategies and address the critical mental health care gap for patients following acute orthopedic injuries.

Optimizing the Implementation of a Lifestyle Dementia Prevention Intervention for Older Patients in an Academic Healthcare System.

Background: Interventions that promote healthy lifestyles are critical for the prevention of Alzheimer's disease and Alzheimer's disease related dementias (AD/ADRD). However, knowledge of the best practices for implementing AD/ADRD prevention in healthcare settings remains limited. Objective: We aimed to qualitatively identify barriers and facilitators to implementing a clinical trial of a novel lifestyle intervention (My Healthy Brain) in our medical center for older patients with subjective cognitive decline who are at-risk for AD/ADRD. Methods: We conducted focus groups with 26 healthcare professionals (e.g., physicians, psychology, nursing) from 5 clinics that treat older patients (e.g., memory care, psychiatry). Our qualitative analysis integrated two implementation frameworks to systematically capture barriers and facilitators to AD/ADRD prevention (Consolidated Framework for Implementation Science Research) that impact implementation outcomes of acceptability, appropriateness, and feasibility (Proctor's framework). Results: We found widespread support for an RCT of My Healthy Brain and AD/ADRD prevention. Participants identified barriers related to patients (stigma, technological skills), providers (dismissiveness of "worried well," doubting capacity for behavior change), clinics (limited time and resources), and the larger healthcare system (underemphasis on prevention). Implementation strategies guided by Expert Recommendations for Implementing Change (ERIC) included: developing tailored materials, training staff, obtaining buy-in from leadership, addressing stigmatized language and practices, identifying "champions," and integrating with workflows and resources. Conclusions: The results will inform our recruitment, enrollment, and retention procedures to implement the first randomized clinical trial of My Healthy Brain. Our study provides a blueprint for addressing multi-level barriers to the implementation of AD/ADRD prevention for older patients in medical settings.

Palliative Care Interventions for Persons With Neurodegenerative Disease: A Scoping Review of Clinical Trial Study Design Features.

Background: Within palliative care research, best practice guidelines to conduct scientifically rigorous clinical trials for neurodegenerative diseases are underexplored. This patient population experiences unique challenges, including fluctuations in cognitive capacity, care partner (CP) and proxy involvement, and high adverse events (AEs), that necessitate special consideration when designing clinical trials. Objective: The objective of this study was to describe and identify clinical trial design features that have been documented in studies involving a neuropalliative intervention for persons with neurodegenerative diseases, highlighting features that have been adapted for this unique patient population. Design: We conducted a scoping review of clinical trials with a neuropalliative intervention for persons with neurodegenerative disease. We searched Cochrane, Web of Science, EMBASE, Scopus, and PubMed (MEDLINE) databases for articles published in English between 1950 and 2023. Two reviewers screened, extracted, and synthesized data from the included articles. A third reviewer adjudicated instances of conflict. The data were analyzed using a thematic framework approach. Results: Of 1025 texts, 44 articles were included. Seven study design features were analyzed: (1) consent, (2) proxies and CPs, (3) recruitment strategies, (4) retention strategies, (5) choice of comparator, (6) AEs, and (7) internal validity. This scoping review found disparities in study design features around structured consent, proxies and CPs, comparators, and AEs. Conclusions: To date, neuropalliative care clinical trials have had varied study designs and the majority of research has focused on dementia. Research guideline development for high-quality neuropalliative care clinical trials is greatly needed across the range of neurodegenerative diseases. To increase the scientific rigor of clinical trials and neuropalliative care, we recommend a standardized capacity assessment for consent, defining conditions for the CP, proxy, and AEs, systematizing appropriate comparators, and outlining preemptive recruitment and retention strategies to address the broader unpredictable challenges of palliative care research.

Minimal clinically important difference in the World Health Organization Quality of Life Brief (WHOQOL-BREF) for adults with neurofibromatosis.

PURPOSE: This study aimed to estimate minimal clinically important difference (MCID) values for the World Health Organization Quality of Life Brief version (WHOQOL-BREF) among adults with neurofibromatosis (NF). An MCID is needed to demonstrate clinical meaningfulness of interventions for NF. METHODS: We estimated MCID for the WHOQOL-BREF: the quality of life (QoL) measure recommended by the Response Evaluation in Neurofibromatosis and Schwannomatosis International Collaboration. We used data from 228 clinical trial participants with NF type 1, NF type 2-related schwannomatosis, or schwannomatosis (SCHWN) who completed 10 weeks of a virtual group mind-body program targeting resiliency or a time- and attention-matched control. Following established guidelines, we estimated MCIDs using both anchor-based and distribution-based methods for physical, psychological, social relationships, and environmental domains of the WHOQOL-BREF. RESULTS: MCID results varied across method and QoL domain. Three anchor-based methods, average change (AC), change difference (CD), and regression (REG), yielded the most consistent and comparable MCID across QoL domains. Based on these methods, we recommend ranges for each QoL domain: Physical QoL (3.9-7.3), Psychological QoL (4.7-8.1), Social QoL (2.6-5.9), and Environmental QoL (4.1-6.6). CONCLUSION: Establishing a rigorous MCID for QoL in NF is a critical step toward evaluating meaningful change in response to psychosocial interventions.

Association Between Subjective Cognitive Decline and Twice-Weekly Muscle-Strengthening Activities in Middle-Aged and Older US Adults: An Analysis of the 2019 Behavioral Risk Factor Surveillance System.

PURPOSE: Adults with subjective cognitive decline (SCD), the self-reported concern of reduced cognitive function, are recommended to do physical activity for its brain health benefits. US adults aged ≥45 with SCD are less likely to meet the American College of Sports Medicine (ACSM) aerobic activity recommendations. Their engagement in muscle-strengthening activities is unknown. We aimed to identify if US adults aged ≥45 with SCD are less likely to do twice-weekly muscle-strengthening activities compared to those without SCD. DESIGN: Secondary analysis of the 2019 Behavioral Risk Factor Surveillance System (BRFSS) data. SAMPLE: 114 164 respondents, representing approximately 59 million US adults aged ≥45. MEASURES: SCD was indicated if the respondent reported confusion or memory loss during the past 12 months (yes/no). Respondents reported the frequency of muscle-strengthening activities, which we categorized as meeting the ACSM's recommendations (2+ times per week) or not (<2 times per week). ANALYSIS: Crude and adjusted logistic regression models controlling for variables associated with SCD and muscle-strengthening activities. The models used sample weights to represent US adults in the included 31 states and Washington D.C. RESULTS: US adults aged ≥45 with SCD were less likely to do twice-weekly muscle-strengthening activities than those without SCD (28.6% [SE: .8%] vs 33.5% [SE: .3%], adjusted OR, .9; 95% CI: .9-1.0). CONCLUSION: Primary care providers should encourage middle-aged and older patients to engage in muscle-strengthening and aerobic activities.